EP3053609B1 - Druckreduzierte dosen mit hydrophoben poren - Google Patents

Druckreduzierte dosen mit hydrophoben poren Download PDF

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Publication number
EP3053609B1
EP3053609B1 EP16163004.1A EP16163004A EP3053609B1 EP 3053609 B1 EP3053609 B1 EP 3053609B1 EP 16163004 A EP16163004 A EP 16163004A EP 3053609 B1 EP3053609 B1 EP 3053609B1
Authority
EP
European Patent Office
Prior art keywords
pores
reduced
pressure
coating
canister
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Revoked
Application number
EP16163004.1A
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English (en)
French (fr)
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EP3053609A1 (de
Inventor
Christopher Brian Locke
Timothy Mark Robinson
Jonathan Paul Jaeb
Richard Daniel John Coulthard
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KCI Licensing Inc
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KCI Licensing Inc
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Application filed by KCI Licensing Inc filed Critical KCI Licensing Inc
Publication of EP3053609A1 publication Critical patent/EP3053609A1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/78—Means for preventing overflow or contamination of the pumping systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/60—Containers for suction drainage, adapted to be used with an external suction source
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/78—Means for preventing overflow or contamination of the pumping systems
    • A61M1/784—Means for preventing overflow or contamination of the pumping systems by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/88—Draining devices having means for processing the drained fluid, e.g. an absorber
    • A61M1/882—Draining devices provided with means for releasing antimicrobial or gelation agents in the drained fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D5/00—Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures
    • B05D5/08—Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures to obtain an anti-friction or anti-adhesive surface
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D7/00—Processes, other than flocking, specially adapted for applying liquids or other fluent materials to particular surfaces or for applying particular liquids or other fluent materials
    • B05D7/02—Processes, other than flocking, specially adapted for applying liquids or other fluent materials to particular surfaces or for applying particular liquids or other fluent materials to macromolecular substances, e.g. rubber
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D7/00—Processes, other than flocking, specially adapted for applying liquids or other fluent materials to particular surfaces or for applying particular liquids or other fluent materials
    • B05D7/50—Multilayers
    • B05D7/52—Two layers
    • B05D7/54—No clear coat specified
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D7/00—Processes, other than flocking, specially adapted for applying liquids or other fluent materials to particular surfaces or for applying particular liquids or other fluent materials
    • B05D7/50—Multilayers
    • B05D7/56—Three layers or more
    • B05D7/58—No clear coat specified
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/98—Containers specifically adapted for negative pressure wound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7563—General characteristics of the apparatus with filters with means preventing clogging of filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49888—Subsequently coating

Definitions

  • the present disclosure relates generally to medical treatment systems and, more particularly, but not by way of limitation, to reduced-pressure canisters having hydrophobic pores.
  • reduced pressure is applied to tissue through a porous pad or other manifold device.
  • the porous pad contains cells or pores or pathways that are capable of distributing reduced pressure to the tissue and channeling fluids that are drawn from the tissue. Reduced pressure may also be used for draining fluids or other applications. The fluids removed are typically delivered to a canister.
  • Prior art document US 2011/152799 A1 discusses a liquid-collection canister which includes a liquid collection chamber defined by at least one wall and a first and second gas-communication pathway formed within the at least one wall.
  • a reduced-pressure treatment system comprising: a reduced-pressure canister comprising: a canister body forming a fluid reservoir, an inlet for receiving fluids from a patient, and a reduced-pressure source fluidly coupled to the fluid reservoir; and a reduced-pressure delivery conduit fluidly coupled to the inlet for delivering fluids from the patient to the reduced-pressure canister, the reduced pressure canister comprising; a vent portion, wherein the vent portion comprises: a plurality of pores, and a hydrophobic coating over the plurality of pores.
  • a method of manufacturing a reduced-pressure canister comprising: forming a canister body with a fluid reservoir and an inlet for receiving fluids from a patient; and, forming a vent portion in the canister body, which in turn comprises the steps of: forming a plurality of pores in a boundary area of the canister body, and applying a hydrophobic coating over the plurality of pores.
  • tissue site 114 of a patient includes a reduced-pressure delivery conduit 112 in fluid communication with a tissue site 114 of a patient.
  • the tissue site may be a wound or defect located on or within any tissue, including but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments.
  • the tissue site may also be an area of any tissue, including wounded or defective as well as areas in which it is desired to add or promote the growth of additional tissue.
  • the reduced-pressure treatment system 110 may be used in certain tissue areas to grow additional tissue that may be harvested and transplanted to another tissue location.
  • the reduced-pressure delivery conduit 112 may fluidly communicate with the tissue site 114 through a tubing adapter 118 and a distribution manifold 122.
  • the distribution manifold 122 may be any material, either bioabsorbable or non-bioabsorbahle, if the material is capable of manifolding a reduced pressure to the tissue site 114.
  • the distribution manifold 122 may be an open-cell, reticulated polyurethane foam.
  • a drape 128 may be placed over the distribution manifold 122 and sealed around a perimeter of the tissue site 114 to maintain reduced pressure at the tissue site 114
  • a coupling provides fluid communication between the reduced-pressure delivery conduit 112 and a reduced-pressure source 134.
  • the reduced- pressure source 134 may be a reduced pressure or vacuum pump driven by a motor.
  • the reduced-pressure source may be a manually-actuated pump such as a compressible bellows pump.
  • the reduced-pressure source 134 may be a wall suction port such as are available in hospitals and other medical facilities.
  • the reduced-pressure source 134 may be housed within a reduced-pressure treatment unit 136, which may also contain sensors, processing units, alarm indicators, memory, databases, software, display units, and user interfaces that further facilitate the application of reduced pressure treatment to the tissue site 114.
  • a sensor (not shown) may be disposed at or near the reduced-pressure source 134 to determine a source pressure generated by the reduced-pressure source 134.
  • the sensor may communicate with a processing unit that monitors and controls the reduced pressure delivered by the reduced-pressure source 134.
  • Delivery of reduced pressure to the tissue site encourages new tissue growth by maintaining drainage of exudate from the tissue site, increasing blood flow to tissues surrounding the tissue site, and by compressing the distribution manifold into the tissue site, thereby creating microstrain at the tissue site which stimulates new tissue growth.
  • a canister 137 having a canister body 142 is fluidly coupled between the reduced-pressure source 134 and the tissue site 114 to collect exudate and other fluids drawn from the tissue site 114.
  • the canister 137 may couple a reduced-pressure source 134 to a reduced-pressure manifold 122 at a tissue site 114, and collect fluids from a wound at the tissue site 114.
  • the canister 137 may be referred to as a reduced-pressure canister.
  • the canister body 142 includes a basin portion 144 and a lid portion 146.
  • the lid portion 146 may be formed by a substantially planar exit wall 148 that is capable of mating with the basin portion 144.
  • a basin wall 150 forms the basin portion 144 and includes curved contours to create a crescent shape.
  • the basin portion 144 and lid portion 146 may instead form a canister body that is cylindrical, cubical, rectangular cubical, or any other shape.
  • the canister body 142 may not include separate basin and lip portions, but rather may be formed from a substantially unitary housing.
  • the canister body 142 includes an inlet 152 fluidly coupled to the reduced-pressure delivery conduit 112, and an outlet, or vent portion 160.
  • the reduced-pressure treatment system 110 may include a canister filter or other in-line protection filter to prevent fluid from entering the reduced-pressure source 134.
  • the vent portion 160 of the canister body 142 comprises a hydrophobic filter to prevent liquid from exiting the canister body 142 through the vent portion 160.
  • the inlet 152 may be positioned on a wall 178 disposed in a recessed region 180 of the basin portion 144.
  • the hydrophobic filter of vent portion 160 prevents liquid egress from the canister body 142 while allowing gases or vapor to exit.
  • a hydrophobic filter may be a hydrophobic membrane welded to the canister body 142 in a window or opening.
  • a plurality of pores 162 are formed in the canister body 142 and covered with a hydrophobic coating (e.g., hydrophobic coating 271 of FIG. 7 ) to form a weld-free hydrophobic filter.
  • the vent portion 160 includes the integral hydrophobic filter formed within the exit wall 148. Integrating the vent portion 160, which includes or otherwise functions as a hydrophobic filter, into the exit wall 148 may be beneficial for a number of reasons.
  • An integral hydrophobic filter removes the need to weld or fix a filter in place as a separate manufacturing step, thereby mitigating concerns related to welding a filter in place, using mechanical fasters, or using adhesives. Such concerns may include localized stresses, weaknesses associated with the weld(s), and material constraints associated with welded materials.
  • an integral filter may reduce the overall cost of the reduced-pressure canister because fewer parts and less labor are needed to assemble a canister body 142 for use in a reduced-pressure treatment system 110 or other medical system requiring a reduced-pressure canister.
  • the vent portion 160 allows fluid communication between the canister body 142 and the reduced-pressure source 134 such that a collection chamber or reservoir portion 166 formed by the canister body 142 can maintain a reduced pressure.
  • This reduced pressure may be transmitted to the tissue site (or other location for a medical application) through the inlet 152.
  • the inlet 152 delivers the reduced pressure to the reduced-pressure delivery conduit 112, the tubing adapter 118, and the distribution manifold 122.
  • the reduced pressure draws exudate and other fluids from the tissue site 114 into the canister body 142.
  • the hydrophobic filter prevents liquids that that are drawn into the canister body 142 from exiting the canister body 142 through the vent portion 160 and contaminating the reduced-pressure source 134.
  • the vent portion 160 is formed with the plurality of pores 162, or apertures, formed within the exit wall 148, and a hydrophobic coating.
  • the hydrophobic coating may be applied to the plurality of pores 162 to form the hydrophobic filter, which is integral to (i.e., formed within) the vent portion 160 and exit wall 148. No welds are required.
  • the integral hydrophobic filter enables the vent portion 160 to function as a liquid-air separator and prevent liquids from passing through the exit wall 148 to the reduced-pressure source 134.
  • the canister body 142 includes the collection chamber 166 or fluid reservoir for collecting fluid within the canister body 142.
  • An entry chamber 170 is positioned above the collection chamber 166.
  • An aperture 190 allows fluid communication between the entry chamber 170 and the collection chamber 166.
  • the inlet 152 may be disposed in the wall 178 such that a primary lumen of the reduced-pressure delivery conduit 112 facilitates communication between the tissue site 114 and the entry chamber 170.
  • the entry chamber 170 further includes a floor 186 that at least partially separates the entry chamber 170 from the collection chamber 166. Despite the presence of the floor 186, fluid communication is permitted between the entry chamber 170 and the collection chamber 166 through the aperture 190.
  • the aperture 190 may be a slot, hole, channel, or any other aperture that allows communication between the entry chamber 170 and the collection chamber 166.
  • the positions and shapes of the inlet 152, vent portion 160, and entry chamber 170 may vary depending on the shape and configuration of the canister. As such, the positions and shapes of the inlet 152, vent portion 160, and entry chamber 170 may differ from the positioning, shapes, and general configurations described above and shown in the related FIGURES 1-7 .
  • a baffle 156 may be provided to reduce the formation of protein bubbles, burst protein bubbles that have formed, and minimize the premature blocking of the vent portion 160.
  • the baffle 156 may have a surfactant coating to reduce the surface energy of the bubbles.
  • FIGURE 3B shows the path of fluid entering the canister body 142.
  • Line 192 schematically depicts the fluid path.
  • the fluid passes through the inlet 152 and into the entry chamber 170. Fluid leaving the entry chamber 170 is directed downward (for the orientation shown) through the aperture 190 at an end of the entry chamber 170.
  • the fluid passes into collection chamber 166. As the fluid enters the collection chamber 166, gravity pulls any liquid in the fluid stream downward to collect in a bottom (for the orientation shown) portion of the collection chamber 166. Gases in the fluid stream may be pulled upward around the baffle 156 to exit the canister body 142 at the vent portion 160.
  • the baffle 156 creates a tortuous pathway (as illustrated, for example, by line 192) for fluid entering and traveling through the canister body 142. This tortuous pathway minimizes the risk of premature blocking of the hydrophobic filter by liquid entering the canister body 142. Additionally, the baffle 156 serves to prevent protein bubbles in the liquid exudate from forming or to block bubbles that have formed from reaching the vent portion 160. The baffle 156 also prevents or substantially reduces line-of-sight between the entry chamber 170 and the vent portion 160.
  • a porous, reticulated foam such as a polyurethane foam may be positioned within the entry chamber 170.
  • the reticulated nature of the foam minimizes bubble formation near the open end of the entry chamber 170, which limits protein deposition on the vent portion 160.
  • other foams or materials may be placed within the entry chamber 170 or between the entry chamber 170 and the vent portion 160 to prevent premature blocking of the hydrophobic filter.
  • a porous foam may be placed anywhere in the canister to prevent or reduce protein deposition on the vent portion 160.
  • FIGURE 4 a schematic, side (interior) perspective view of the lid portion 146 of the canister body 142 of FIGURE 1 is presented.
  • FIGURE 4 shows a vent portion 160 that may be formed on the inner surface of a lid portion 146 (or a wall) in a number of ways, as detailed in FIGURES 5A-5C .
  • a plurality of pores 162 are formed in a portion of the exit wall 148 of the lid portion 146.
  • the plurality of pores 162 may be micro-drilled, and as such may be generally circular in shape.
  • the exit wall 148 is a part of the lid portion 146 of the canister body 142 and may be formed in an injection molding process.
  • the exit wall 148 is a flat area of accurate constant wall thickness where a filter can be located.
  • vent portions 160 include or form an integral hydrophobic filter, i.e., a hydrophobic filter formed within the exit wall 148.
  • the vent portion 160 is formed from a plurality of pores 162 that are micro-holes formed in the exit wall 148.
  • the pores 162 may be formed with an excimer laser or any other suitable manufacturing technique.
  • the pores 162 may also be formed by photo or chemical etching.
  • the diameter (D) of each of the plurality of pores 162 may be between 0.25 and 1 micron, or any other suitable size, and the quantity of pores 162 may be varied so that the cumulative flow rate through the pores 162 is sufficient for the flow of the system.
  • the pores 162 may be formed in a pattern or randomly.
  • the pores 162 may be sized to function as a barrier to bacteria or viruses.
  • the plurality of pores 162 may have a diameter of, for example, 0.5 to 1 microns.
  • the plurality of pores 162 may have a smaller diameter of, for example, 0.25 micron.
  • the size of the pores may even be adjusted to provide protection against specific types of bacteria. Generally, holes of 1 micron in diameter, arranged in a tortuous path, are sufficiently small to prevent the passage of some bacteria and fluid through a hydrophobic filter operated at low level differential pressures.
  • FIGURE 5B presents another illustrative embodiment in which the vent portion 160 is formed from a plurality of micro-slits 262 formed in the exit wall 148 instead of holes.
  • the micro-slits 262 are sized with a lateral gap such that the micro-slits 262 function analogously to pores 162.
  • the micro-slits 262 may be formed using any technique mentioned herein for the pores or machining.
  • FIGURE 5C presents another illustrative embodiment that includes a separate grate member 364 that includes a second set of micro-slits 362, also shown in FIGURE 6 .
  • the grate member 364 may be formed separately from the exit wall 148 and affixed to the exit wall 148 such that the micro-slits 362 of the grate member 364 substantially overlie and are perpendicular to the micro-slits 262 of the exit wall 148 grate.
  • the intersections of the micro-slits 262 and 362 will create a set of micro-holes 363 that allow gases to pass through the vent portion 160 of the exit wall 148.
  • the micro-holes 363 function analogously to the pores 162.
  • the entire vent portion 160 may be formed in a grate member 364 that may be sealably coupled to an open area in an end wall 148 of a canister body 142.
  • Desired hydrophobic properties may be given to the vent portion 160 by applying a surface treatment process to the vent portion 160 of the reduced-pressure canister over the apertures, e.g., pores 162, micro-slits 262, or micro-holes 363.
  • a surface treatment process is shown in FIGURE 7 below.
  • an illustrative lid portion 146 of a canister 137 is presented with a plurality of micro-slits 262 formed in the exit wall 148 on a vent portion 160.
  • the plurality of holes may be covered with a hydrophobic coating.
  • a lid portion 146 of a reduced-pressure canister is presented being treated in a plasma treatment chamber (not explicitly shown).
  • a plasma coating unit 270 receives a gas 272 and passes the gas 272 between a nozzle that includes a cathode 274 and anode 273.
  • An arc between the cathode 274 and anode 273 ionizes the gas and causes the gas to dissociate and form a plasma stream 275, into which the coating material 271 is injected.
  • the plasma stream heats the coating material to a workable or depositable state.
  • Other processes for delivering the hydrophobic coating may be used.
  • the item to be coated may be placed within a chamber into which the treatment chemical is introduced and ionized.
  • the heated plasma stream 275 cools as the plasma stream 275 moves away from the plasma coating unit 270.
  • the work piece e.g., the canister lid portion 146
  • the work piece e.g., the canister lid portion 146
  • a plasma deposition process deposits a hydrophobic coating onto the vent portion 160 portion of the lid portion 146 of the canister 137.
  • the coating may be a fluorocarbon, heptadecafluorodecylacylate, acrylates containing haloalkyl (e.g., fluoroalkyl) or perhaloalkyl (e.g.
  • the hydrophobic coating chemically bonds to the substrate, i.e., to the exit wall 148 of the lid portion 146 of the canister, to resist mobility or removal of the hydrophobic coating from the substrate.
  • the reduced-pressure treatment unit 136 may include a pressure sensor that monitors the pressure of the reduced-pressure treatment unit 136.
  • a canister includes a hydrophobic filter
  • the hydrophobic filter prevents liquid from passing through the exit wall until the pressure differential between the fluid reservoir of the canister body 142 and the reduced-pressure treatment unit 136 reaches the breakthrough pressure of the filter, "P(b)."
  • the reduced-pressure unit may monitor the pressure differential between the canister body 142 and the reduced-pressure treatment unit 136. Before the pressure differential reaches the breakthrough pressure, P(b), of the hydrophobic filter, the reduced-pressure treatment unit 136 may deactivate the reduced-pressure source, thereby preventing fluid from entering the reduced-pressure treatment unit 136.
  • the breakthrough pressure, P(b), of a hydrophobic filter resulting from the plasma treatment process is a function of the size of the holes that form the filter, the surface tension of the liquid, and the contact angle of the surface.
  • the contact angle of the surface is a measure of the hydrophobicity of the surface.
  • the hydrophobic filter has a "water breakthrough pressure" of approximately 500 mm Hg.
  • the deposited hydrophobic coating may advantageously show higher water repellence than more traditional PTFE based filters that provide an effective oleo-phobic or hydrophobic coating.
  • Neutralizing odors may also be a concern when collecting fluids from a wound in a reduced-pressure treatment system.
  • a charcoal filter may be welded in place above the plurality of pores 162 on the internal face of the lid portion 146 of the canister body 142. Use of the charcoal filter helps to ensure that air moved through the holes does not cause odor.
  • a charcoal filter may also be welded into the same location on the external sealing face of the canister body 142.
  • a charcoal coating may be applied to or included in a portion of the canister body 142, which may include the vent portion, using a plasma surface treatment similar to the process described with regard to FIGURE 7 .
  • the canister body 142 primarily collects exudate from the tissue site 114 or functions to collect liquid in other medical applications. Exudates from a small percentage of patients have unique chemical and physical properties. These properties promote bubble formation and foaming as fluid enters the canister, and the fluid may contain proteins that can adhere to many hydrophobic filter membranes. Under normal conditions, the protein film builds up gradually but protein film build-up may be exacerbated by the presence of foaming that causes the exudate to bubble. The presence of "exudate bubbles" maximizes the rate of protein adherence by atomizing minute droplets of protein-containing exudate when the bubbles pop. The small size of these droplets limits the liquid-shedding effects of the hydrophobic filter, and encourages their rapid evaporation.
  • the vent portion 160 may be coated with a protease during the plasma treatment process.
  • the protease coating has the effects of an enzyme and may cause protein breakdown in the area of the filter to prevent build up and blockage of the filter.
  • Such a coating may act as an anti-fouling layer in addition to preventing proteins from clogging the filter.
  • an integral hydrophobic filter as an aspect of the vent portion 160
  • other coatings may be applied to other portions of the canister body 142 by applying alternate coatings.
  • other portions of the canister body 142 may be coated with solidifying agents to stabilize or change the state of liquids that are collected in the canister body 142.
  • Such a coating may reduce the need for a super-absorbent pouch in some reduced-pressure treatment systems.
  • the inside of a canister body 142 may be coated with a bactericide that would kill or render bacteria inactive and reduce or eliminate odors.
  • a charcoal coating may also be applied to reduce the need for the charcoal filter to eliminate odors.
  • the reduced-pressure conduit may be treated using a plasma treatment process so that fluids entering the conduit and canister body experience less drag when entering the canister.
  • This type of coating may increase the efficiency of the tube and in turn increase the ability of the reduced-pressure treatment unit to function more accurately and efficiently.
  • a hydrophobic filter that is integral to the canister body 142 may have other beneficial attributes as compared to a welded filter or a filter assembled to the canister body using another manufacturing process. For example, a wider selection of materials may be available to form the filter because the material will not need to be welded. Further, the filter can be formed on surfaces that arc less conducive to welding, allowing a filter to be easily formed within a curved canister wall. In the case of a welded filter, the weld may also present a point of weakness in the canister and a bad filter weld can result in the ingress of liquids to the reduced-pressure treatment unit.
  • a plasma treatment process coating may also be "gamma stable,” i.e., able to withstand gamma radiation without being destabilized.
  • Some materials used to create hydrophobic coatings, such as PTFE, may not be able to sustain gamma radiation without undergoing undesirable changes in their polymer structure.
  • materials other than PTFE may be more easily applied.
  • heptadecafluorodecylacylate a more gamma stable polymer, may be applied using the plasma treatment process.
  • a hydrophobic filter element can be made that withstands sterilization using gamma radiation without breaking down.
  • the plasma coated solution has the beneficial attribute of being immobile once deposited.
  • the applied coating will bond and coat the entire surface of the vent portion 160, including the internal surfaces of micro-holes or other apertures that have been formed in the lid portion 146 (e.g., pores 162).
  • the coated pores 162 may provide an even greater repellence to liquid entry because the pores 162 will have a nominally smaller diameter, thereby increasing the breakthrough pressure, P(b), of the filter.
  • the surface tension of any liquids that come into contact with the pores 162 will also have to be overcome in order for fluid to pass through the filter.
  • the plasma treatment process can be used to apply multiple coatings to apply different chemical groups, offering a plurality of functionality. As such, hydrophobic, hydrophilic, anti-protein, and anti-bacterial coatings may be applied.
  • a method for forming a hydrophobic filter within a reduced-pressure canister body includes forming a canister body 142 with a designated area to serve as a vent portion 160.
  • the method also includes perforating the designated area to populate the area with very small apertures, for example pores 162 having a diameter of between .25 and 1 microns.
  • the method involves applying a hydrophobic coating to the designated area as previously described.
  • the hydrophobic coating is a fluorocarbon, such as heptadecafluorodecylacylate.
  • the integral hydrophobic filter of the canister body functions as both a fluid outlet and a liquid-air separator that allows gases to flow out of the canister but retains liquids within the canister.
  • the method may include minimizing the susceptibility of the filter to occlusion resulting from the deposition of proteins from the wound exudate on the vent portion 160. Minimization or prevention of protein deposition may occur in several different ways, including by providing a baffle or porous foam, or by depositing a protease with the hydrophobic coating of the canister. In this way, protein deposition may further be minimized or prevented by preventing proteins from reaching the hydrophobic filter or by enzymatically breaking down any proteins that reach the filter.
  • the illustrative embodiments described herein may be used with reduced-pressure treatment systems of any type, shape, or size and similarly with canisters of any type, shape, or size.
  • the location of the inlet, outlet, and vent portion with an integral hydrophobic filter may also vary depending upon the particular reduced-pressure canister design.
  • the geometry of the vent portion and hydrophobic filter may be modified as necessary to conform to the contours or configuration of the reduced-pressure canister.
  • the vent portion and hydrophobic filter are not limited to use with a reduced-pressure treatment system.
  • the vent portion and hydrophobic filter may also be used with other medical collection canisters that include liquid-air separators.

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Claims (16)

  1. Behandlungssystem (110) mit einem reduzierten Druck, das umfasst:
    einen Kanister (137) reduzierten Drucks, der umfasst:
    einen Kanisterkörper (142), der ein Fluidreservoir (166) bildet, und
    einen Einlass (152) zum Aufnehmen von Fluiden von einem Patienten,
    eine Quelle (134) reduzierten Drucks, die fluidtechnisch mit dem Fluidreservoir (166) verbunden ist; und
    eine Zuführleitung (112) reduzierten Drucks, die fluidtechnisch mit dem Einlass (152) verbunden ist, um Fluide von dem Patienten dem Kanister (137) reduzierten Drucks zuzuführen,
    dadurch gekennzeichnet, dass der Kanister (137) reduzierten Drucks umfasst:
    einen Lüftungsabschnitt (160), wobei der Lüftungsabschnitt (160) umfasst:
    eine Vielzahl von Poren (162), und
    eine hydrophobe Beschichtung (271) über der Vielzahl von Poren (162).
  2. System nach Anspruch 1, wobei jede der Vielzahl von Poren (162) einen Durchmesser in dem Bereich von 0,5 Mikrometer bis 1 Mikrometer aufweist.
  3. System nach Anspruch 1 oder 2, wobei die hydrophobe Beschichtung (271) Fluorkohlenstoff umfasst.
  4. System nach Anspruch 1, 2 oder 3, wobei die hydrophobe Beschichtung (271) Heptadecafluorodecylacylat umfasst.
  5. System nach Anspruch 1, 2, 3 oder 4, wobei der Lüftungsabschnitt (160) eine oder mehrere aus: antimikrobieller Beschichtung, antibakterieller Beschichtung, Proteasebeschichtung oder Aktivkohlebeschichtung umfasst.
  6. System nach Anspruch 1, 3, 4, oder 5, wobei jede Pore der Vielzahl von Poren (162) einen Durchmesser in dem Bereich von 0,5 bis 1 Mikrometer aufweist und wobei ein Durchbruchsdruck des Lüftungsabschnitts (160) definiert ist durch die Gleichung: P b = 4 ⁢ g cos q / D ,
    Figure imgb0002
     wobei
    P(b) der Durchbruchsdruck des Lüftungsabschnitts (160) ist,
    g die Oberflächenspannung der Flüssigkeit ist,
    q der Kontaktwinkel zwischen der Oberfläche des Lüftungsabschnitts (160) ist, und
    D der Durchmesser einer Pore ist.
  7. System nach einem der vorstehenden Ansprüche, wobei der Lüftungsabschnitt (160) keine Schweißnähte aufweist.
  8. System nach einem der vorstehenden Ansprüche, wobei die Vielzahl von Poren (162) eine erste Vielzahl an Parallelschlitzen (262) umfasst, wobei das System ferner ein Gitterelement (364) umfasst, das eine zweite Vielzahl an Parallelschlitzen (362) umfasst, wobei die hydrophobe Beschichtung (271) an dem Gitterelement (364) aufgetragen ist, wobei das Gitterelement (364) derart über der ersten Vielzahl an Parallelschlitzen (262) positioniert ist, dass die zweite Vielzahl an Parallelschlitzen (362) im Wesentlichen die erste Vielzahl an Parallelschlitzen (262) überlagert und senkrecht dazu ist.
  9. Verfahren zum Herstellen eines Kanisters (137) reduzierten Drucks, das umfasst:
    Bilden eines Kanisterkörpers (142) mit einem Fluidreservoir (166) und einem Einlass (152) zum Aufnehmen von Fluiden von einem Patienten; und gekennzeichnet durch:
    Bilden eines Lüftungsabschnitts (160) in dem Kanisterkörper (142), was wiederum die Schritte umfasst: Bilden einer Vielzahl von Poren (162) in einem Grenzbereich des Kanisterkörpers (142) und Auftragen einer hydrophoben Beschichtung (271) über den mehreren Poren (162).
  10. Verfahren nach Anspruch 9, wobei der Schritt des Auftragens einer hydrophoben Beschichtung (271) über der Vielzahl von Poren (162) ein Auftragen der hydrophoben Beschichtung (271) in einem Plasmabehandlungsverfahren umfasst.
  11. Verfahren nach Anspruch 9 oder 10, wobei der Schritt des Auftragens einer hydrophoben Beschichtung (271) über der Vielzahl von Poren (162) ein Auftragen einer Beschichtung aus Fluorkohlenwasserstoff umfasst.
  12. Verfahren nach Anspruch 9, 10 oder 11, wobei der Schritt des Auftragens einer hydrophoben Beschichtung (271) über der Vielzahl von Poren (162) ein Auftragen einer Beschichtung aus Heptadecafluorodecylacylat umfasst.
  13. Verfahren nach Anspruch 9, 10, 11 oder 12, wobei der Schritt des Bildens einer Vielzahl von Poren (162) ein Bilden einer Vielzahl von Poren (162) mit einem Durchmesser in einem Bereich von 0,5 bis 1 Mikrometer umfasst.
  14. Verfahren nach Anspruch 9, 10, 11, 12 oder 13, wobei der Schritt des Bildens eines Kanisterkörpers (142) vorsehen eines Kanisterkörpers (142), der aus PET-Polymer gebildet ist, umfasst.
  15. Verfahren nach Anspruch 9, 10, 11, 12, 13 oder 14, das weiter Auftragen mindestens einer der folgenden Beschichtungen über der Vielzahl von Poren (162) in einem Plasmabehandlungsverfahren umfasst: eine antimikrobielle Beschichtung, eine antibakterielle Beschichtung und/oder eine Aktivkohlebeschichtung.
  16. Verfahren nach Anspruch 9, 10, 11, 12, 13, 14 oder 15, wobei der Schritt des Auftragens einer hydrophoben Beschichtung (271) über der Vielzahl von Poren (162) ein Auftragen einer Proteasebeschichtung über der Vielzahl von Poren (162) in einem Plasmabehandlungsverfahren umfasst.
EP16163004.1A 2011-09-13 2012-08-10 Druckreduzierte dosen mit hydrophoben poren Revoked EP3053609B1 (de)

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AU2012309115A1 (en) 2014-02-20
US9327063B2 (en) 2016-05-03
US20160213822A1 (en) 2016-07-28
US10980924B2 (en) 2021-04-20
CN103796692B (zh) 2016-06-22
JP2014526309A (ja) 2014-10-06
JP6189845B2 (ja) 2017-08-30
CN106110411B (zh) 2018-11-06
EP2755696A1 (de) 2014-07-23
WO2013039623A1 (en) 2013-03-21
EP2755696B1 (de) 2016-04-06
AU2012309115B2 (en) 2016-10-13
CA2844480C (en) 2020-10-13
CA2844480A1 (en) 2013-03-21
CN106110411A (zh) 2016-11-16
CN103796692A (zh) 2014-05-14
EP3053609A1 (de) 2016-08-10

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